Empirical CPAP Therapy for Suspected Obstructive Sleep Apnea in a Resource-Limited Setting
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University
About this trial
Obstructive sleep apnea (OSA) is a condition where a person's airway repeatedly collapses during sleep, causing them to stop breathing briefly and disrupting their rest. The standard way to diagnose OSA is a formal overnight sleep study called polysomnography (PSG). However, in resource-limited settings, sleep study centers are scarce, which can lead to months of waiting before a patient can be diagnosed and treated. Delaying treatment can negatively affect a patient's quality of life and increase their risk for other health issues.
The purpose of this observational study is to evaluate the clinical benefits of starting continuous positive airway pressure (CPAP) therapy early for patients who are highly suspected to have OSA, while they wait for their formal sleep study.
Researchers will enroll adult patients who have symptoms of OSA (such as loud snoring, witnessed breathing pauses, and severe daytime sleepiness) and a high clinical probability of having the condition. Instead of waiting for the official sleep study to begin treatment, these participants will be provided with an Auto-CPAP machine set to a practical pressure range.
The main goals of the study are to evaluate:
* If this early, empirical Auto-CPAP treatment improves patients' daytime sleepiness and overall quality of life, which will be measured using specialized questionnaires. * How accurately the temporary Auto-CPAP machine's pressure settings match the final, optimal pressure settings that will eventually be determined by the formal sleep study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
Patients presenting with symptoms suggestive of OSA, including one or more of the following: excessive daytime sleepiness, habitual snoring, witnessed apnea during sleep, non-restorative sleep, or morning headache.
High clinical probability of OSA defined by: STOP-BANG score ≥5 or STOP-BANG score 3-4 with ESS ≥10.
Patients awaiting diagnostic PSG due to delayed access to sleep laboratory services.
Disqualifiers
Age <18 years.
Pregnancy.
Previous PSG-confirmed OSA with prescribed CPAP settings.
Predominant central sleep apnea.
Trial population
The study population consists of adult patients (aged 18 years and older) attending the Chest Department at Assiut University Hospital who present with symptoms suggestive of Obstructive Sleep Apnea (OSA), such as excessive daytime sleepiness, habitual snoring, or witnessed apnea. Eligible patients must have a high clinical probability of OSA, defined as having a STOP-BANG score of 5 or greater, or a STOP-BANG score of 3 to 4 combined with an Epworth Sleepiness Scale (ESS) score of 10 or greater. Furthermore, the population is specifically composed of individuals who are currently awaiting diagnostic polysomnography (PSG) due to delayed access to sleep laboratory services in a resource-limited setting.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
80 Participants
are grouped into 1 trial groupGroup A: Suspected OSA Patients on Empirical Auto-CPAP
Trial outcomes
Primary outcomes
1
Change in Epworth Sleepiness Scale (ESS) Score
The Epworth Sleepiness Scale (ESS) is used to assess daytime sleepiness. It consists of 8 specific situations where the patient rates their chance of dozing on a scale from 0 (would never doze) to 3 (high chance of dozing). The total score is calculated by summing the item responses, resulting in a possible range of 0 to 24. Higher scores indicate higher levels of daytime sleepiness, with scores of 10 or greater suggesting excessive sleepiness that may require medical attention. This outcome will report the change in the total ESS score to evaluate clinical improvement.
Time frame
Baseline and 1 month post CPAP initiationSecondary outcomes
1
Change in Functional Outcomes of Sleep Questionnaire (FOSQ-10) Score
The FOSQ-10 is a 10-item self-administered questionnaire designed to assess the impact of excessive sleepiness on daily activities across five domains: vigilance, general productivity, social outcomes, intimacy, and activity level. Each item is rated on a 1 to 4 scale, where 1 indicates extreme difficulty and 4 indicates no difficulty performing the activity due to sleepiness or tiredness. The total score is calculated by summing the responses, resulting in a possible range of 5 (maximum impairment) to 20 (no impairment). This outcome will report the change in the total score to evaluate the improvement in quality of life.
Time frame
Baseline and 1 month post CPAP initiationLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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